NCT06548529招募中不适用
Al18F-HER2-BCH PET/CT to Predict Response in Bladder Cancer Patients Treated With HER2 ADC
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SUV
研究概览
简要总结
To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value of HER2 expression in bladder cancer patients treated with HER2 ADC
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged # 18 years old; ECOG 0 or 1;
- •Is unresectable or metastatic;
- •Patients with HER2 positive or suspicious positive tumors;
- •was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane;
- •Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
- •Receives anti-HER2 ADC treatment
- •Life expectancy > 3 months
排除标准
- •Significant hepatic or renal dysfunction;
- •Is pregnant or ready to pregnant;
- •Cannot keep their states for half an hour;
- •Refused to join the clinical research;
- •Suffering from claustrophobia or other mental disorders;
- •Any other situation that researchers considered it unsuitable to participate in the trial.
结局指标
主要结局
SUV
时间窗: 4 years
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
次要结局
未报告次要终点
研究者
研究点 (1)
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